Cook Medical recalled 5,080 Spectrum Central Venous Catheter Sets worldwide after labeling that indicated expiration dates beyond the products' true shelf life. The recall alerts patients and healthcare providers to stop using affected lots and follow manufacturer instructions.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Spectrum Central Venous Catheter Sets are used for vascular access in critical care, delivering medications and fluids to patients. They come in multiple configurations to fit different patient needs.
Labels showing expiration dates beyond true shelf life could misrepresent product validity and potentially affect device integrity.
This recall is not part of a broader industry pattern.
The recall primarily affects healthcare facilities and patients who may be using mislabeled expiration data. It requires facility-level action to verify lots and arrange replacements or disposal.
UDI (01) embedded in product labeling and lot numbers on packaging
Replacement or remediation timelines vary by facility; expect several weeks to months depending on supply.
Document lot numbers, UDIs, dates, and communication with providers and manufacturers.
Recall pertains to Spectrum Central Venous Catheter Sets with multiple reference part numbers and order numbers listed in the recall notice. Affected lots include various UDI codes and lot numbers such as Lot 15569919, 15520378, 15487727, 15484947, 16617145, NS16617419, and NS16617420. Distribution is worldwide.
No specific injuries or adverse events are reported in the provided recall data.
Not sure what to do next? Our guide walks you through the process step by step.
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